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NCT01222247 · ClinicalTrials.gov registry record · Phase 3

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

A Phase 3 study, sponsored by The George Washington University Biostatistics Center.

Completed
Registry status
Phase 3
Development phase
2,831
Enrollment target

NCT01222247 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 2,831 participants.

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The verdict

NCT01222247, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.

COMPLETED
Registry status
Phase 3
Development phase
2,831 participants
Enrollment target

Study Summary

This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period

Interventions

  • DRUG Placebo
  • DRUG Betamethasone

Trial Details

FieldValue
Enrollment Target 2,831 participants
Start Date 2010-10
Est. Completion 2022-08-31
Phase Phase 3

What the Registry Record Tells You About NCT01222247

The ClinicalTrials.gov registry entry for NCT01222247 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,831 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01222247 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01222247 about?

NCT01222247 is a clinical study titled "Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial". This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been s...

What is the current status of trial NCT01222247?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,831 participants. The study started on 2010-10. Estimated completion is 2022-08-31.

What interventions are being tested in trial NCT01222247?

The interventions under investigation include: Placebo (DRUG), Betamethasone (DRUG).

Who is sponsoring clinical trial NCT01222247?

This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.